Last reviewed · How we verify
Parallel Phase I Study of Ixabepilone Plus Lapatinib and Ixabepilone Plus Lapatinib Plus Capecitabine in Subjects With HER2 Positive Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to determine the safety and preliminary effectiveness of ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal growth factor receptor 2 (HER2)-positive or metastatic breast cancer.
Details
| Lead sponsor | R-Pharm |
|---|---|
| Phase | Phase 1 |
| Status | TERMINATED |
| Enrolment | 13 |
| Start date | 2008-06 |
| Completion | 2010-06 |
Conditions
- Locally Advanced or Metastatic Breast Cancer
Interventions
- Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg
- Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg
- Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg
- Ixabepilone + Lapatinib + Capecitabine
Primary outcomes
- Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Ixabepilone When Administered With Lapatinib — Days 1 through 21
The MTD is defined as the maximum dose that can be administered to 6 participants such that no more than 1 (or fewer than one third if more than 6 participants receive treatment) experiences a dose-limiting toxicity (DLT), with at least 2 experiencing a DLT at the next higher dose level. The RP2D is based on the MTD and the assessment of any relevant chronic toxicities. - MTD and RP2D of Ixabepilone When Administered With Lapatinib Plus Capecitabine — Days 1 through 21
MTD is defined as the maximum dose that can be administered to 6 participants such that no more than 1 (or fewer than one third if more than 6 participants receive treatment) experiences a DLT, with at least 2 experiencing a DLT at the next higher dose level. The RP2D is based on the MTD and the assessment of any relevant chronic toxicities.
Countries
United States, Australia, Italy